CN115068415A - Prefilled heparin sodium tube-sealing injection and preparation method thereof - Google Patents
Prefilled heparin sodium tube-sealing injection and preparation method thereof Download PDFInfo
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- CN115068415A CN115068415A CN202210584509.XA CN202210584509A CN115068415A CN 115068415 A CN115068415 A CN 115068415A CN 202210584509 A CN202210584509 A CN 202210584509A CN 115068415 A CN115068415 A CN 115068415A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/727—Heparin; Heparan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
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Abstract
The invention belongs to the technical field of medicines, and particularly discloses a prefilled heparin sodium tube-sealing injection and a preparation method thereof. The pre-filled heparin sodium tube-sealing injection consists of heparin sodium, sodium hydroxide and normal saline in the concentration of 10-100 units/mL, and the prepared heparin sodium saline solution is filled into a pre-filled syringe of random copolymer polypropylene with good transparency, high glossiness and precipitation resistance and is prepared into a finished product after high-pressure steam sterilization. By controlling the pH value and the autoclaving condition of the prepared heparin sodium salt aqueous solution, the impurity content in the heparin sodium tube-sealing injection is finally reduced remarkably, the stability of the heparin sodium tube-sealing injection is improved, and the medication safety of the heparin sodium tube-sealing injection is further ensured.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a prefilled heparin sodium tube-sealing injection and a preparation method thereof.
Background
The tube sealing is an important link for ensuring the effective application of the indwelling needle technology clinically, and is mainly used for keeping the vein indwelling devices such as the indwelling needle, the venous catheter and the like smooth and preventing the vein indwelling devices from being blocked. The low-concentration heparin sodium solution is the first-choice tube sealing solution for the venous indwelling needle, and is generally prepared by diluting a high-concentration heparin sodium injection into physiological saline clinically, and then performing tube sealing operation.
The pre-filled catheter flusher is a novel product, and is characterized in that a tube flushing and sealing liquid is pre-filled into an injector, so that the tube flushing and sealing operation can be directly carried out during use, and the traditional method for manually preparing the tube sealing liquid is replaced. The novel product has wide application range and simple operation, can reduce the pollution chance, reduce the infection risk, simultaneously avoid the occurrence of the needle stick injury of medical personnel, has high safety, also reduces the operation time, and has clinical advantages.
The prefilled catheter flusher currently on the market at home only contains a canned product of normal saline, and the prefilled heparin sodium tube-sealing injection containing heparin sodium is only available on the market in the countries such as the United states, Japan and the like, so that new products are urgently needed to be developed in China to meet the clinical requirements.
The polypropylene material adopted by the injector of the pre-filled heparin sodium tube-sealing injection sold in the market at present has the problems of poor transparency and more dissolved substances. The random copolymer polypropylene has improved transparency due to its low crystallinity. In order to improve the situation, a prefilled syringe made of random copolymerization polypropylene materials with good transparency, high glossiness and precipitation resistance is used for preparing heparin sodium into prefilled tube-sealed injection, but in the research and development process, the problems that related substances of the heparin sodium tube-sealed injection are remarkably increased and the titer of the heparin sodium is reduced in the storage process are found, and the medication safety cannot be guaranteed.
Therefore, the development of the heparin sodium tube-sealing injection which is suitable for preparing the pre-filled syringe by the random copolymerization polypropylene material with good transparency, high glossiness and precipitation resistance and can ensure the medication safety has very important significance.
Disclosure of Invention
The invention aims to provide a prefilled heparin sodium tube-sealing injection of an injector made of random copolymerization polypropylene materials, which has the advantages of good transparency, high glossiness and precipitation resistance, and a preparation method thereof, aiming at the defects of the prior art. The injection syringe made of the random copolymerization polypropylene material with good transparency, high glossiness and precipitation resistance is adopted, and the pH range of the prepared heparin sodium salt aqueous solution and the proper sterilization pressure and temperature are controlled to prepare a product with excellent quality, so that the impurity content in the heparin sodium tube-sealed injection is finally obviously reduced, the stability of the heparin sodium tube-sealed injection is improved, and the medication safety of the heparin sodium tube-sealed injection is further ensured.
In order to realize the purpose of the invention, the following technical scheme is adopted:
a preparation method of prefilled heparin sodium tube-sealing injection is characterized by comprising the following steps:
step a, adding heparin sodium and sodium chloride with the prescription amount into injection water with the total volume of 70-80%, stirring and dissolving, adjusting the pH value to 5.8-7.2, adding the injection water to the total preparation amount, mixing uniformly, and filtering to obtain a heparin sodium salt aqueous solution;
and b, filling the heparin sodium salt aqueous solution into a pre-filled syringe of random copolymerization polypropylene, and performing high-pressure steam sterilization under the conditions that the pressure is saturated vapor pressure plus 2.3 atm-saturated vapor pressure plus 2.8atm and the temperature is 117-119 ℃ to obtain the pre-filled heparin sodium tube-sealing injection.
Furthermore, in the preparation method of the prefilled heparin sodium tube-sealing injection, the time for high-pressure steam sterilization is 15min to 19 min.
Furthermore, in the step a of the preparation method of the prefilled heparin sodium tube-sealing injection, the pH value is adjusted to 5.8-7.2 by using an aqueous solution of sodium hydroxide.
Furthermore, in the step a of the preparation method of the prefilled heparin sodium tube-sealing injection, the filtration is performed by a 0.22-0.45 micron microporous filter membrane.
In step b of the method for preparing the prefilled heparin sodium catheter lock injection, the random copolymer polypropylene is preferably polypropylene GM1900E or polypropylene GM 1600E.
The invention also provides a prefilled heparin sodium tube-sealing injection, and the injection is prepared by the preparation method of the prefilled heparin sodium tube-sealing injection.
Further, the specification of the prefilled heparin sodium catheter-sealing injection is 5mL:500 units, 5mL:50 units, 10mL:500 units and 10mL:50 units.
Furthermore, the pH value of the prefilled heparin sodium tube-sealing injection is 5.6-6.8.
The invention has the following effects:
(1) researches show that only by simply replacing the material of the injector with the random copolymerization polypropylene material with good transparency, high glossiness and precipitation resistance, the product quality can not be well ensured, and still based on the conception of the invention, the injector made of the random copolymerization polypropylene material with good transparency, high glossiness and precipitation resistance can be adopted, and simultaneously, the product with excellent quality can be prepared under the optimal pH range of the adjusting solution and the appropriate sterilization pressure and temperature.
(2) The invention preferably adds sodium hydroxide solution to adjust the pH range of the solution to 5.8-7.2 in the process of preparing the prefilled heparin sodium tube-sealed injection, and the prepared sterilization conditions are that the pressure is saturated vapor pressure +2.3 atm-2.8 atm and the temperature is 117-119 ℃, and the titer of the product and the indexes of related substances can meet the requirements through the parameter control, and the level of quality standard is further improved.
(3) The invention particularly obviously improves the quality standard of the related substance dermatan sulfate, realizes that the related substance dermatan sulfate is controlled to be below 0.25 percent after accelerating for 6 months, and obviously improves the control level of impurities compared with the limit requirement of the related substance in the existing quality standard that the related substance dermatan sulfate is not more than 2.0 percent, thereby ensuring the medication safety.
(4) The pre-filled syringe material selected by the invention has high transparency, so that the condition of the content of the syringe is more conveniently observed, and the detection of the product properties is conveniently and accurately carried out.
(5) The prefilled heparin sodium tube-sealing injection disclosed by the invention is simple in prescription, only contains heparin sodium and saline, does not contain any other additives, is small in irritation and low in anaphylactic reaction, improves the compliance of patients, and is convenient to use clinically.
Detailed Description
The following detailed description of the invention is provided to facilitate an understanding of the invention and to enable any person skilled in the art to make or use the invention without limiting it.
Example 1
The present example provides a prefilled heparin sodium tube-sealing injection, which is 5 mL/500 units, and the dosage of the prescription for preparing 1000 tubes is shown in the following table:
the preparation method comprises the following steps:
adding the heparin sodium and sodium chloride with the prescription amount into 4L of water for injection, stirring and dissolving, adding a sodium hydroxide aqueous solution to adjust the pH of the solution to 6.0, adding the rest water for injection to 5L in total, mixing uniformly, and filtering with a 0.45-micron microporous filter membrane to obtain the heparin sodium aqueous solution. 5mL of this solution was filled in a polypropylene GM1900E prefilled syringe, sealed by fitting a screw cap to the tip of the syringe barrel, and autoclaved at 118 ℃ for 15 minutes under the condition of saturated vapor pressure +2.6atm, to obtain a prefilled heparin sodium-capped injection. The medicine is colorless transparent aqueous injection, has pH of 5.8, and osmotic pressure ratio of about 1 (ratio to normal saline).
Example 2
The embodiment provides a prefilled heparin sodium tube-sealing injection, the specification is 5mL:50 units, and the dosage of the prescription for preparing 1000 tubes is shown in the following table:
the preparation method comprises the following steps:
adding heparin sodium and sodium chloride in the amount of the prescription into 3.5L of water for injection, stirring for dissolving, adding a sodium hydroxide aqueous solution to adjust the pH of the solution to 5.8, adding the rest water for injection to 5L in total, mixing uniformly, and filtering with a 0.30 mu m microporous filter membrane to obtain a heparin sodium aqueous solution. 5mL of the solution was filled in a polypropylene GM1600E prefilled syringe, sealed by fitting a screw cap on the tip of the syringe barrel, and autoclaved at 117 ℃ for 19 minutes under the saturated vapor pressure +2.3atm condition, to obtain a prefilled heparin sodium-sealed tube injection. The medicine is colorless transparent aqueous injection, has pH of 5.6, and osmotic pressure ratio of about 1 (ratio to normal saline).
Example 3
The present example provides a prefilled heparin sodium tube-sealing injection, which is 10mL in 500 units, and the dosage of the prescription for preparing 1000 tubes is shown in the following table:
the preparation method comprises the following steps:
adding heparin sodium and sodium chloride in the amount of the prescription into 8L of water for injection, stirring and dissolving, adding a sodium hydroxide aqueous solution to adjust the pH of the solution to 6.6, adding the rest water for injection to 10L in total, mixing uniformly, and filtering with a 0.22 mu m microporous filter membrane to obtain the heparin sodium aqueous solution. 10mL of the solution was filled in a polypropylene GM1600E prefilled syringe, sealed by fitting a screw cap on the tip of the syringe barrel, and autoclaved at 119 ℃ for 17 minutes under the saturated vapor pressure +2.8atm condition, to obtain a prefilled heparin sodium-sealed tube injection. The medicine is colorless transparent aqueous injection, has pH of 6.3, and osmotic pressure ratio of about 1 (ratio to normal saline).
Example 4
The present example provides a prefilled heparin sodium tube-sealing injection, which is 10mL in 50 units, and the dosage of the prescription for preparing 1000 tubes is shown in the following table:
the preparation method comprises the following steps:
adding the heparin sodium and sodium chloride with the prescription amount into 7L of water for injection, stirring and dissolving, adding a sodium hydroxide aqueous solution to adjust the pH of the solution to 7.2, adding the rest water for injection to 10L in total, mixing uniformly, and filtering by a 0.45-micron microporous filter membrane to obtain the heparin sodium aqueous solution. 10mL of the solution was filled into a polypropylene GM1900E prefilled syringe, sealed by fitting a screw cap to the tip of the syringe barrel, and autoclaved at 118 ℃ for 16 minutes under the saturated vapor pressure +2.5atm, to obtain a prefilled heparin sodium-sealed tube injection. The medicine is colorless transparent aqueous injection, has pH of 6.8, and osmotic pressure ratio of about 1 (ratio to normal saline).
The pre-filled syringe in embodiments 1-4 includes a syringe barrel, a plunger rod, a screw cap, and a gasket. The pre-filled syringe is prepared by a conventional method, which comprises the following steps:
(1) preparation of syringe barrel, plunger rod and screw cap
a. And (3) vacuum drying: carrying out vacuum drying on the random copolymerization polypropylene granules of the required type for 3-6 hours at the temperature of 45-55 ℃ for later use;
b. injection molding: and adding the dried granules into a hopper of an injection molding machine, performing injection molding according to various specifications of syringe parts, and respectively performing injection molding to obtain a syringe barrel, a plunger rod and a screw cap of a pre-filled syringe with 5mL or 10 mL.
(2) Preparation of gaskets
The unvulcanized rubber sheet containing chlorinated butyl rubber was vulcanized and molded at 175 ℃ for 10 minutes by a vacuum compressor to obtain a vulcanized rubber sheet, which was further punched, washed, sterilized and dried to obtain a desired gasket.
(3) Assembled product
And assembling all parts of the prepared pre-filled syringe to obtain the random copolymer polypropylene pre-filled syringe.
Test example 1
Samples were prepared according to the preparation method of example 1, wherein the pH of the solution was adjusted by adding sodium hydroxide solution under various conditions shown in Table 1, and then the prepared samples were subjected to accelerated test at 40 ℃ and 75% +/-5% relative humidity for 3 months, and the titer and related substances of the samples were measured with time, and the results are shown in Table 1.
Wherein, the potency is determined by heparin bioassay method (2020 edition of Chinese pharmacopoeia), the related substances are determined by the method in patent CN103323541B, the controlled quality standard is that the potency is 90-110% of the labeled amount, and the related substances dermatan sulfate is not more than 2.0%.
TABLE 1 influence of pH on product quality
The data in table 1 show that when the pH is within the range of 5.8-7.2, the titer is over 104% at 0 month, the related substance dermatan sulfate is under 0.05%, after accelerated 3 months, the titer does not change greatly, the titer is over 101%, the related substance does not increase much, and the related substance dermatan sulfate is under 0.15%; however, in the range of pH less than 5.8 and more than 7.2, at 0 month, compared with the case of pH in the range of 5.8-7.2, the titer is reduced to 100% -102.5%, the related substances are also increased to 0.13% -0.31%, particularly after accelerated test for 3 months, the titer is remarkably reduced to 70% -85%, which is far lower than the requirement of quality standard, the related substances are also remarkably increased, and the related substance dermatan sulfate is between 0.40% -1.10%, which is still in the range of quality standard.
Therefore, the pH value of the solution is preferably adjusted to 5.8-7.2 by adding sodium hydroxide solution.
Test example 2
Samples were prepared according to the preparation method of example 1, in which sterilization pressure and temperature were performed under various conditions shown in Table 2, and then the prepared samples were subjected to accelerated test at a high temperature of 40 ℃ and a relative humidity of 75% +/-5% for 3 months, and the titer and related substances of the samples were measured with time, and the results are shown in Table 2. The detection method of the potency and related substances is the same as above.
TABLE 2 Effect of Sterilization conditions on product quality
From the data in table 2, it is known that the titer is over 106% and related substance dermatan sulfate is 0.01% at 0 month under the conditions of the sterilization pressure of saturated vapor pressure +2.3atm to saturated vapor pressure +2.8atm and the temperature of 117-119 ℃, and after the test of accelerating for 3 months, the titer change is not large, over 104%, the related substance is not increased much and related substance dermatan sulfate is 0.04%; if the sterilization condition is in the same pressure range, but the temperature is below 117 ℃ or above 119 ℃, the titer is slightly reduced within 0 month, and between 104.3-105.6%, the related substances are slightly increased, and between 0.02-0.04%, after the test of accelerating for 3 months, the titer is obviously changed, and between 98.5-102.1%, the quality standard requirement is still met, and the related substances are slightly increased, and between 0.05-0.10%; if the pressure range of the sterilization condition is below the saturated vapor pressure plus 2.3atm or above the saturated vapor pressure plus 2.8atm and the temperature is 115-123 ℃, the titer is reduced to 98-101% in 0 month, the related objects are obviously increased to 0.26-0.53%, after 3 months of accelerated test, the titer is obviously reduced to 70-81%, the titer is far lower than the requirement of the quality standard, the related objects are also obviously increased to 0.92-2.32%, and the requirements of individual conditions on not meeting the quality standard exist.
The air tightness of the injection can be affected by the sterilization condition, and the impurities of the injection can be increased due to the influence of the external environment. Through the detection research on related substances of the injection, the optimal sterilization conditions are finally found, wherein the pressure is between the saturated vapor pressure and 2.3atm and the saturated vapor pressure and 2.8atm, and the temperature is 117-119 ℃.
In a word, the sodium hydroxide solution is preferably added in the process of preparing the prefilled heparin sodium tube-sealed injection to regulate the pH value of the solution to be 5.8-7.2, the prepared sterilization conditions are that the pressure is saturated vapor pressure plus 2.3 atm-saturated vapor pressure plus 2.8atm, and the temperature is 117-119 ℃, and the titer of the product and related material indexes can be ensured to meet the requirements through the parameter control, and the level of the quality standard is further improved.
Test example 3
The samples prepared in examples 1 to 4 were subjected to an accelerated test at 40 ℃ and 75% +/-5% relative humidity for 6 months, and the properties, titer and related substances of the samples were measured with time, and the results are shown in Table 3. The detection method of the potency and related substances is the same as above.
TABLE 3 accelerated test results
As shown in the data in Table 3, the potency of each of examples 1 to 4 was 95% or more and the related substance dermatan sulfate was 0.25% or less after 6 months of accelerated test, and the properties were all acceptable. The invention particularly and remarkably improves the quality standard of the related substance dermatan sulfate, realizes that the related substance dermatan sulfate is controlled to be below 0.25 percent after accelerating for 6 months, and remarkably improves the control level of impurities compared with the limit requirement of the related substance in the existing quality standard that the related substance dermatan sulfate is not more than 2.0 percent.
Meanwhile, the syringe material adopted by the invention has high transparency, so that the condition of the content of the syringe is more conveniently observed, and the detection of the product properties is conveniently and accurately carried out.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents or improvements made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (8)
1. A preparation method of prefilled heparin sodium tube-sealing injection is characterized by comprising the following steps:
step a, adding heparin sodium and sodium chloride in a prescription amount into injection water with the total volume of 70-80%, stirring and dissolving, adjusting the pH to 5.8-7.2, adding the injection water to the total preparation amount, mixing uniformly, and filtering to obtain a heparin sodium salt aqueous solution;
and b, filling the heparin sodium salt aqueous solution into a prefilled syringe of random copolymer polypropylene, and performing high-pressure steam sterilization under the conditions that the pressure is saturated steam pressure plus 2.3 atm-saturated steam pressure plus 2.8atm and the temperature is 117-119 ℃ to obtain the prefilled heparin sodium tube-sealed injection.
2. The method for preparing the prefilled heparin sodium catheter-sealing injection according to claim 1, wherein the time for the high-pressure steam sterilization is 15-19 min.
3. The method for preparing the prefilled heparin sodium tube-sealed injection according to claim 1, wherein in step a, the pH is adjusted to 5.8-7.2 by using an aqueous solution of sodium hydroxide.
4. The method for preparing prefilled heparin sodium catheter lock injection according to claim 1, wherein in step a, the filtration is performed through a microporous membrane of 0.22 μm to 0.45 μm.
5. The method for preparing prefilled heparin sodium lock injection according to claim 1, wherein in step b, the random copolymer polypropylene is polypropylene GM1900E or polypropylene GM 1600E.
6. A prefilled heparin sodium tube-sealing injection, which is characterized by being prepared by the preparation method of the prefilled heparin sodium tube-sealing injection according to any one of claims 1 to 5.
7. The prefilled heparin sodium lock syringe injection of claim 6, wherein the standard of said prefilled heparin sodium lock syringe injection is 5mL:500 units, 5mL:50 units, 10mL:500 units or 10mL:50 units.
8. A pre-filled heparin sodium tube-sealing injection as claimed in claim 6, wherein the pH of the pre-filled heparin sodium tube-sealing injection is 5.6-6.8.
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| CN202210584509.XA CN115068415A (en) | 2022-05-26 | 2022-05-26 | Prefilled heparin sodium tube-sealing injection and preparation method thereof |
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| CN202210584509.XA CN115068415A (en) | 2022-05-26 | 2022-05-26 | Prefilled heparin sodium tube-sealing injection and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103932981A (en) * | 2014-04-02 | 2014-07-23 | 张波 | Heparin sodium tube-sealing injection |
| CN104558854A (en) * | 2013-10-28 | 2015-04-29 | 中国石油化工股份有限公司 | Polypropylene composition for ampoule bottle |
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- 2022-05-26 CN CN202210584509.XA patent/CN115068415A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104558854A (en) * | 2013-10-28 | 2015-04-29 | 中国石油化工股份有限公司 | Polypropylene composition for ampoule bottle |
| CN103932981A (en) * | 2014-04-02 | 2014-07-23 | 张波 | Heparin sodium tube-sealing injection |
Non-Patent Citations (1)
| Title |
|---|
| 徐敏中 * |
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